Conductive electrode for electrosurgical handpiece and manufacturing method therefor

This application is a U.S. National Stage Application of International Application No. PCT/KR2021/019366, filed on Dec. 20, 2021, which claims the benefit under 35 USC 119(a) and 365(b) of Korean Patent Application No. 10-2020-0188948, filed on Dec. 31, 2020 and Korean Patent Application No. 10-2021-0065249, filed on May 21, 2021, in the Korean Intellectual Property Office, the entire disclosure of which is incorporated herein by reference for all purposes.

The present disclosure relates to a monopolar handpiece conductive electrode used for an electrosurgical handpiece and, more particularly, an aspect of the present disclosure is to provide an electrosurgical handpiece conductive electrode and a method for manufacturing the same, wherein minimal tissue carbonization and smog occur during surgery, and no tissue adheres to the electrode.

Conventionally, iron-made surgical scalpels have been used to conduct tissue incision surgeries, and are still widely used today. However, as a result of highly developed modern engineering technologies, cutting-edge surgical tools that use energy such as electricity, laser, or ultrasonic waves have appeared.

The principle of energy-based surgical instruments is as follows: energy is appropriately injected into the tissue of a human body such that the tissue is changed, thereby having a surgical effect.

The most widely used energy-based surgery among them is electrosurgery, which refers to a surgical method in which high-frequency or radio-frequency electric energy is used to incise, excise, or cauterize a patient's tissue.

Human nervous systems react very sensitively to low-frequency electricity of up to 1,000 Hz. Therefore, if exposed to domestic AC electricity, humans will get electric shocks.

Electrosurgery using high-frequency electric energy uses high-frequency electricity ranging from 200 kHz to 5 MHz.

Electric energy supplied through an electrode generates vibrations inside cells, and the temperature inside the cells increases, thereby heating the tissue.

If the temperature inside the cells reaches about 60° C., cell death occurs. If heated to 60-90° C., the tissue is dried (dehydrated), and protein coagulation proceeds. If the temperature inside the cells reaches 100° C., cells undergo volume expansion and vaporization. The tissue is incised or cauterized in such processes.

As such, electrosurgery uses high-frequency electric currents to incise and coagulate tissue. When an electrosurgical device is used to incise tissue by a high-frequency electric current, heat is generated, thereby causing a noticeable coagulation effect.

Such electrosurgical incision inevitably generates an arc at a high temperature as the air insulating layer is destroyed by incomplete contact between the conductive electrode and tissue. The arc burns tissue (burn damage). There is also a problem in that the conductive electrode is contaminated by tissue carbonization.

In addition, tissue carbonization by the arc results in smog, which is known to have adverse health influence on the surgeon and the patient.

As illustrated in, the monopolar electrosurgery instrumenthas a conductive electrodefastened to the front of a handpiecein, which is held by the surgeon, and has a ground padgrounded on the patient. The handpieceand the ground padare connected to a control unit, which generates high-frequency waves, by cables, respectively.

There is a problem in that, when the conventional conductive electrodeis used to conduct electrosurgery, incomplete contact between the conductive electrodeand tissue generates a high-temperature arc, thereby resulting in tissue carbonization and smog, and the tissue adheres to the surface of the conductive electrodeand contaminates the same, making it necessary to frequently clean or replace the conductive electrode.

The present disclosure has been made to solve the above-mentioned problems, and it is an aspect of the present disclosure to provide an electrosurgical handpiece conductive electrode and a method for manufacturing the same, wherein the conductive electrode is configured to have a high level of insulation and non-stickiness such that tissue carbonization and smog do not occur during an electrosurgery, and no tissue adheres to the electrode surface, which is thus not contaminated.

A method for manufacturing an electrosurgical handpiece conductive electrode according to the present disclosure includes: a blade molding step Sof molding a bladein a plate type by using aluminum as a material such that a plugis provided on one side of the blade; an anodizing coating step Sof anodizing the bladeso as to form an anodizing coating layerhaving a thickness of 30-80 μm on a surface thereof; a primary edge portion processing step Sof forming an edge portionby removing the anodizing coating layerformed on a peripheral part of the blade; and a non-sticky coating step Sof forming a non-sticky coating layeron the surface of the bladewhich has undergone the anodizing coating step.

The non-sticky coating layermay be formed to have a thickness of 10-40 μm by using ceramic as a material.

Alternatively, the non-sticky coating layermay be formed to have a thickness of 10-30 μm by using polytetrafluoroethylene (PTFE) such as Teflon™ as a material.

In addition, the method may further include a secondary edge portion processing step Sof removing the ceramic coating layerformed on the edge portion of the bladethrough the ceramic coating step S.

In addition, the anodizing coating layerformed in the anodizing coating step Smay have a thickness of 40 μm, and the ceramic coating layerformed in the ceramic coating step Smay have a thickness of 30 μm.

In addition, in the primary edge portion processing step S, a part of the anodizing coating layerformed on the periphery of the blademay be removed such that the edge portionis formed only on a part of the periphery of the blade.

In addition, an electrosurgical handpiece conductive electrode according to the present disclosure is manufactured by the above-mentioned method.

A conductive electrode according to the present disclosure, configured as described above, has an anodizing coating surface formed on a blade surface such that tissue carbonization and smog do not occur during an electrosurgery, and has a non-stick coating layer formed on the blade surface such that no tissue adheres to the blade surface, thereby enabling the surgeon to concentrate on surgery because the electrode does not need to be cleaned frequently.

Hereinafter, the present disclosure will be described in detail with reference to exemplary embodiments of the present disclosure and the accompanying drawings, assuming that identical reference numerals in the drawings denote identical components.

The description used in the detailed description of the present disclosure or in the claims that a component “includes” another component is to be understood as meaning that the former component may include other components, and is not to be limited to the interpretation that the same includes only the latter component, unless otherwise specified.

As used herein, terms such as “upper portion”, “lower portion”, “bottom”, “front”, “rear”, and “below” are only intended to facilitate the description, and denote the orientation of components as illustrated in the drawings.

A conductive electrodeused for a handpieceof an electrosurgical instrument incises, excises, or cauterizes tissue by using high-frequency electric energy supplied to the electrode.

The conductive electrodeof the present disclosure is used for a handpieceof a monopolar electrosurgical instrument, and as in, the conductive electrodeis fastened to the front of the handpiece.

As illustrated in, the conductive electrode has a bladeformed in a plate shape, has an edge portionformed on the peripheral part of the blade, and has a plugformed behind the blade.

The bladeand the edge portionare parts configured to incise or excise tissue. The plugis inserted into the handpieceso as to supply electric energy to the blade(the role of an electric wire).

is a sectional view illustrating the configuration of a bladeof a conductive electrodeaccording to the present disclosure.

The bladeof a conductive electrodeaccording to the present disclosure has an anodizing coating layerand a non-stick coating layerformed on the surface thereof, except for the edge portion.

The conductive electrodeaccording to the present disclosure is molded by using, as the material, aluminum, which has excellent conductivity and processability.

In addition, as in, an anodizing coating layeris formed on the surface of the blade.

The anodizing coating layer, formed as such, plays the role of electric insulation while increasing the surface rigidity of the blade.

No anodizing coating layeris formed on the edge portionas in. If the anodizing coating layeris formed on the edge portion, which emits electric energy, no surgery is possible because no electric energy is emitted.

By forming the anodizing coating layeron the outer surface of the blade, except for the edge portion, electric energy is emitted from the edge portiononly such that, by increasing the current density, incision and excision are facilitated, and tissue carbonization and smog do not occur due to arc generation because no electric energy is emitted from the side surface of the blade.

In addition, a non-stick coating layeris formed on the anodizing layer.

The non-stick coating layerprevents tissue from adhering to the surface of the bladeduring surgery and contaminating the blade.

In the case of a conventional conductive electrode, a part of tissue adheres to the surface of the bladeduring electrosurgery and carbonizes, thereby contaminating the same. The surgeon thus needs to frequently clean the bladeduring a surgical procedure, and the conductive electrode needs to be replaced frequently because the part that has adhered to the bladeand carbonized is not easily cleaned.

The conductive electrodeaccording to the present disclosure has a non-stick coating layerformed on the surface of the bladesuch that no tissue adheres to the blade, making it unnecessary to frequently clean the bladeduring the surgical procedure, and the electrode does not need to be replaced until the surgery is over.

A method for manufacturing a conductive electrode according to the present disclosure, which is configured as described above, will now be described in detail.

A method for manufacturing a conductive electrode according to the present disclosure includes, as illustrated in, a blade molding step S, an anodizing coating step S, a primary edge portion processing step S, a non-sticky coating step S, and a secondary edge portion processing step S.

Firstly, as in, aluminum is processed to mold a plate-type bladeand a plugon one side of the bladein the blade molding step S.

The blademolded in a plate type through the blade molding step Sis subjected to soft anodizing such that an anodizing coating layeris formed as in.

The anodizing coating layeris an oxide film (aluminum oxide, AlO) which increases the surface rigidity of surface aluminum, and which is obtained by electrolyzing the bladewith a diluted acid solution across the positive electrode, for electric insulation, such that the same is strongly attached to the bladeby oxygen generated at the positive electrode.

According to the present disclosure, the anodizing coating layeris formed on the bladeof the conductive electrodeto have a thickness of 30-80 μm.

If the anodizing coating layerhas a thickness of less than 30 μm, tissue carbonization may occur due to insufficient insulation. If the thickness of the anodizing coating layerexceeds 80 μm, cracks may occur on the coating layer during manufacturing or circulation processes, and an electric discharge may occur through the gaps. Therefore, the anodizing coating layerpreferably has a thickness of 30-80 μm.

After the anodizing coating step S, an edge portion is formed on the bladeof the conductive electrodein a primary edge portion processing step S.